Common Midol Side Effects


The most commonly reported Midol side effects (click to view or check a box to report):

Dizziness (61)
Dysmenorrhoea (53)
Nausea (49)
Vomiting (48)
Dyspnoea (36)
No Adverse Event (35)
Hypersensitivity (26)
Somnolence (25)
Fatigue (24)
Headache (21)
Anxiety (21)
Feeling Jittery (19)
Tremor (18)
Abdominal Pain Upper (17)
Chest Pain (16)
Heart Rate Increased (15)
Dyspepsia (15)
Urticaria (14)
Palpitations (13)
Syncope (12)

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If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Midol Side Effects Reported to FDA



Midol Side Effect Report#9985668
Dermatitis Herpetiformis
This is a report of a 18-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dysmenorrhoea, who was treated with Midol Extended Relief Caplet (dosage: 2 Df, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dermatitis Herpetiformis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Midol Extended Relief Caplet treatment in female patients, resulting in Dermatitis Herpetiformis side effect.
Midol Side Effect Report#9914537
Pruritus, Pruritus
This report suggests a potential Midol Extended Relief Caplet Pruritus side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: abdominal discomfort and used Midol Extended Relief Caplet (dosage: 1 Df, Unk) starting NS. After starting Midol Extended Relief Caplet the patient began experiencing various side effects, including: Pruritus, PruritusAdditional drugs used concurrently:
  • Aleve Caplet
  • Carbidopa
  • Amlodipine
  • Januvia
Although Midol Extended Relief Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pruritus, may still occur.
Midol Side Effect Report#9815778
Pharyngeal Oedema, Pruritus, Urticaria
This Pharyngeal Oedema problem was reported by a consumer or non-health professional from US. A 33-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 02, 2014 this consumer started treatment with Midol Menstrual Complete Formula (dosage: 2 Df, Once). The following drugs were being taken at the same time: NA. When using Midol Menstrual Complete Formula, the patient experienced the following unwanted symptoms/side effects: Pharyngeal Oedema, Pruritus, UrticariaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pharyngeal Oedema, may become evident only after a product is in use by the general population.
Midol Side Effect Report#9803075
Hallucination, Dyspnoea, Syncope, Palpitations
This Hallucination side effect was reported by a consumer or non-health professional from US. A 19-year-old female patient (weight:NA) experienced the following symptoms/conditions: dysmenorrhoea.The patient was prescribed Midol Menstrual Complete Formula (drug dosage: 2 Df, Once), which was initiated on 201310. Concurrently used drugs: NA..After starting to take Midol Menstrual Complete Formula the consumer reported adverse symptoms, such as: Hallucination, Dyspnoea, Syncope, PalpitationsThese side effects may potentially be related to Midol Menstrual Complete Formula.
Midol Side Effect Report#9796372
Nausea, Dizziness, Tremor
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dysmenorrhoea, who was treated with Midol Extended Relief Caplet (dosage: 1 Df, Prn, start time: 2010), combined with: NA. and developed a serious reaction and side effect(s): Nausea, Dizziness, Tremor after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Midol Extended Relief Caplet treatment in female patients, resulting in Nausea side effect.
Midol Side Effect Report#9796367
Dizziness, Tremor, Nausea
This report suggests a potential Midol Extended Relief Caplet Dizziness side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dysmenorrhoea and used Midol Extended Relief Caplet (dosage: 1 Df, Prn) starting 2013. After starting Midol Extended Relief Caplet the patient began experiencing various side effects, including: Dizziness, Tremor, NauseaAdditional drugs used concurrently: NA. Although Midol Extended Relief Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dizziness, may still occur.
Midol Side Effect Report#9791501
Extra Dose Administered
This Extra Dose Administered problem was reported by a consumer or non-health professional from US. A 22-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dysmenorrhoea. On 201309 this consumer started treatment with Midol Extended Relief Caplet (dosage: 3 Or 4 Df, Prn). The following drugs were being taken at the same time: NA. When using Midol Extended Relief Caplet, the patient experienced the following unwanted symptoms/side effects: Extra Dose AdministeredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Extra Dose Administered, may become evident only after a product is in use by the general population.
Midol Side Effect Report#9791498
Dizziness, Tremor, Nausea
This Dizziness side effect was reported by a consumer or non-health professional from US. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: dysmenorrhoea.The patient was prescribed Midol Extended Relief Caplet (drug dosage: 1 Df, Prn), which was initiated on 2010. Concurrently used drugs: NA..After starting to take Midol Extended Relief Caplet the consumer reported adverse symptoms, such as: Dizziness, Tremor, NauseaThese side effects may potentially be related to Midol Extended Relief Caplet.
Midol Side Effect Report#9790359
Dizziness, Vision Blurred, Speech Disorder, Palpitations, Euphoric Mood
This is a report of a 22-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dysmenorrhoea, who was treated with Midol Extended Relief Caplet (dosage: 2 Df, Prn, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dizziness, Vision Blurred, Speech Disorder, Palpitations, Euphoric Mood after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Midol Extended Relief Caplet treatment in female patients, resulting in Dizziness side effect.
Midol Side Effect Report#9766269
Pre-existing Condition Improved
This report suggests a potential Midol Extended Relief Caplet Pre-existing Condition Improved side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Midol Extended Relief Caplet (dosage: 1 Df, Other) starting
Dec 03, 2013. After starting Midol Extended Relief Caplet the patient began experiencing various side effects, including: Pre-existing Condition ImprovedAdditional drugs used concurrently:
  • Zocor
  • Lomax [albendazole]
  • Spiriva
Although Midol Extended Relief Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pre-existing Condition Improved, may still occur.
Midol Side Effect Report#9746479
Euphoric Mood, Fatigue, Incorrect Dose Administered
This Euphoric Mood problem was reported by a consumer or non-health professional from US. A 14-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dysmenorrhoea,pain. On NS this consumer started treatment with Midol (dosage: NA). The following drugs were being taken at the same time:
  • Ibuprofen 600 Mg
  • Sertraline
When using Midol, the patient experienced the following unwanted symptoms/side effects: Euphoric Mood, Fatigue, Incorrect Dose AdministeredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Euphoric Mood, may become evident only after a product is in use by the general population.
Midol Side Effect Report#9739183
Off Label Use
This Off Label Use side effect was reported by a consumer or non-health professional from US. A 15-year-old female patient (weight:NA) experienced the following symptoms/conditions: headache,breast tenderness,fatigue,pain,nausea,mood swings.The patient was prescribed Midol Menstrual Complete Formula (drug dosage: 3 Df, Prn), which was initiated on NS. Concurrently used drugs: NA..After starting to take Midol Menstrual Complete Formula the consumer reported adverse symptoms, such as: Off Label UseThese side effects may potentially be related to Midol Menstrual Complete Formula.
Midol Side Effect Report#9733731
Self Injurious Behaviour, Extra Dose Administered, Somnolence, Agitation, Vomiting
This is a report of a 18-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Midol Pm (dosage: 12 Df, Once, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Self Injurious Behaviour, Extra Dose Administered, Somnolence, Agitation, Vomiting after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Midol Pm treatment in female patients, resulting in Self Injurious Behaviour side effect.
Midol Side Effect Report#9730945
Lip Swelling, Eye Pruritus, Throat Irritation
This report suggests a potential Midol Extended Relief Caplet Lip Swelling side effect(s) that can have serious consequences. A 24-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Midol Extended Relief Caplet (dosage: Unk Unk, Once) starting
Nov 27, 2013. After starting Midol Extended Relief Caplet the patient began experiencing various side effects, including: Lip Swelling, Eye Pruritus, Throat IrritationAdditional drugs used concurrently: NA. Although Midol Extended Relief Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lip Swelling, may still occur.
Midol Side Effect Report#9722485
Affective Disorder, Anxiety, Off Label Use
This Affective Disorder problem was reported by a consumer or non-health professional from US. A 15-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dysmenorrhoea. On NS this consumer started treatment with Midol Extended Relief Caplet (dosage: Unk). The following drugs were being taken at the same time: NA. When using Midol Extended Relief Caplet, the patient experienced the following unwanted symptoms/side effects: Affective Disorder, Anxiety, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Affective Disorder, may become evident only after a product is in use by the general population.
Midol Side Effect Report#9716841
Extra Dose Administered, Disorientation, Headache, Musculoskeletal Discomfort, Malaise
This Extra Dose Administered side effect was reported by a consumer or non-health professional from US. A 21-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Midol Extended Relief Caplet (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Midol Extended Relief Caplet the consumer reported adverse symptoms, such as: Extra Dose Administered, Disorientation, Headache, Musculoskeletal Discomfort, MalaiseThese side effects may potentially be related to Midol Extended Relief Caplet.
Midol Side Effect Report#9708390
Nasal Oedema
This is a report of a 19-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dysmenorrhoea, who was treated with Midol Extended Relief Caplet (dosage: 2 Df, Prn, start time: 2010), combined with:
  • Midol Menstrual Complete Formula (2 Df, Prn)
and developed a serious reaction and side effect(s): Nasal Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Midol Extended Relief Caplet treatment in female patients, resulting in Nasal Oedema side effect.
Midol Side Effect Report#9696051
Extra Dose Administered, Abdominal Pain
This report suggests a potential Midol Menstrual Complete Formula Extra Dose Administered side effect(s) that can have serious consequences. A 15-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Midol Menstrual Complete Formula (dosage: 20 Df, Qd) starting
Nov 14, 2013. After starting Midol Menstrual Complete Formula the patient began experiencing various side effects, including: Extra Dose Administered, Abdominal PainAdditional drugs used concurrently: NA.The patient was hospitalized. Although Midol Menstrual Complete Formula demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Extra Dose Administered, may still occur.
Midol Side Effect Report#9690755
Nausea, Somnolence, Nausea
This Nausea problem was reported by a consumer or non-health professional from US. A 31-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On NS this consumer started treatment with Midol Extended Relief Caplet (dosage: NA). The following drugs were being taken at the same time:
  • Midol Pm
When using Midol Extended Relief Caplet, the patient experienced the following unwanted symptoms/side effects: Nausea, Somnolence, NauseaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Midol Side Effect Report#9624261
Nausea, Vomiting
This Nausea side effect was reported by a consumer or non-health professional from US. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: dysmenorrhoea.The patient was prescribed Midol Extended Relief Caplet (drug dosage: 1 Df, Prn), which was initiated on NS. Concurrently used drugs:
  • Midol Pm (1 Df, Prn)
.After starting to take Midol Extended Relief Caplet the consumer reported adverse symptoms, such as: Nausea, VomitingThese side effects may potentially be related to Midol Extended Relief Caplet.
Midol Side Effect Report#9619371
Extra Dose Administered
This is a report of a 52-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dysmenorrhoea, who was treated with Midol Extended Relief Caplet (dosage: Unk Unk, Prn, start time: 201309), combined with: NA. and developed a serious reaction and side effect(s): Extra Dose Administered after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Midol Extended Relief Caplet treatment in female patients, resulting in Extra Dose Administered side effect.
Midol Side Effect Report#9619366
Nausea, Vomiting
This report suggests a potential Midol Extended Relief Caplet Nausea side effect(s) that can have serious consequences. A 28-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dysmenorrhoea and used Midol Extended Relief Caplet (dosage: 1 Df, Prn) starting 1997. After starting Midol Extended Relief Caplet the patient began experiencing various side effects, including: Nausea, VomitingAdditional drugs used concurrently:
  • Midol Pm (1 Df, Prn)
Although Midol Extended Relief Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nausea, may still occur.
Midol Side Effect Report#9610881
Intentional Overdose, Vomiting
This Intentional Overdose problem was reported by a consumer or non-health professional from US. A 15-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Midol Extended Relief Caplet (dosage: 26 Df, Unk). The following drugs were being taken at the same time: NA. When using Midol Extended Relief Caplet, the patient experienced the following unwanted symptoms/side effects: Intentional Overdose, VomitingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Intentional Overdose, may become evident only after a product is in use by the general population.
Midol Side Effect Report#9587468
Eye Swelling
This Eye Swelling side effect was reported by a consumer or non-health professional from US. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: dysmenorrhoea.The patient was prescribed Midol Extended Relief Caplet (drug dosage: 1 Df, Prn), which was initiated on
Aug 30, 2013. Concurrently used drugs: NA..After starting to take Midol Extended Relief Caplet the consumer reported adverse symptoms, such as: Eye SwellingThese side effects may potentially be related to Midol Extended Relief Caplet.
Midol Side Effect Report#9528688
Therapeutic Response Unexpected
This is a report of a 31-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Midol Extended Relief Caplet (dosage: 2 Df, Prn, start time: 2012), combined with:
  • Valium
  • Ambien
and developed a serious reaction and side effect(s): Therapeutic Response Unexpected after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Midol Extended Relief Caplet treatment in male patients, resulting in Therapeutic Response Unexpected side effect.


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The appearance of Midol on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Midol Side Effects for Women?

Women Side Effects Reports
Dizziness 60
Dysmenorrhoea 53
Nausea 47
Vomiting 46
Dyspnoea 36
No Adverse Event 33
Somnolence 25
Fatigue 24
Hypersensitivity 24
Anxiety 21

What are common Midol Side Effects for Men?

Men Side Effects Reports
Erection Increased 3
Aggression 2
Amnesia 2
Cheilitis 2
Confusional State 2
Dyspepsia 2
Dysuria 2
Erythema 2
Gastric Haemorrhage 2
Genital Erythema 2

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Midol reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Midol Side Effects

    Did You Have a Midol Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Midol for You?

    Exceeded Expectations
    Effective
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    Not Effective

    Midol Safety Alerts, Active Ingredients, Usage Information

    NDC 0280-8005
    Type HUMAN OTC DRUG
    Proprietary Name Midol Complete ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE
    Name TABLET
    Dosage Form ORAL
    Route 20140210
    On market since Bayer HealthCare LLC, Consumer Care
    Labeler ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
    Active Ingredient(s) 500; 60; 15
    Strength(s) mg/1; mg/1; mg/1
    Unit(s)
    Pharma Class

    More About Midol

    Side Effects reported to FDA: 433

    Midol safety alerts: 2012

    Reported deaths: 5

    Reported hospitalizations: 27

    Isovue (iopamidol injection) Pre-Filled Power Injector Syringes by Bracco Diagnostics Inc.: Recall - Presence of Particulates

    [Posted 11/28/2012]

    AUDIENCE: Risk Manager, Cardiology

    ISSUE: Bracco Diagnostics Inc. (BDI) is voluntarily initiating a Class I recall of nine (9) lots of Isovue (iopamidol injection) Pre-Filled Power Injector Syringes (Isovue PFS, to be used in combination with Stellant CT Injection Systems) due to the presence of visible particles in syringes observed at the end of standard stability studies on retained samples.These products were distributed to wholesalers and distributors nationwide. BDI has received no reports of adverse events or customer complaints associated with these lots. However, it should be noted that the visible particles in the lots subject to this recall have the potential to cause adverse health consequences. The dates for distribution of the nine (9) affected lots were from January 21, 2010 through May 9, 2012. For a list of products affected see the Firm Press Release.
     

    BACKGROUND:  Isovue is indicated for angiography throughout the cardiovascular system, and arterial injection of Isovue (for cerebral angiography) with particulate matter formation could cause stroke.

    Isovue PFS is a single use item, administered for diagnostic imaging under medical supervision. The product is packaged in single dose Prefilled Syringe (PFS) presentations of Isovue - 300 FLS2 and Isovue - 370 FLS2.

    RECOMMENDATION: Hospitals, Emergency Rooms, Clinics, Physician Offices and other healthcare facilities and providers should not use these lots of Isovue PFS and should immediately quarantine product and contact Stericycle, Bracco’s contractor for handling the recall, at 1-866-201-9133 to arrange for return of the product.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [11/27/12 - Firm Press Release - Bracco Diagnostics]

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